MAUDE Adverse Event Report: TERUMO EUROPE N.V K-PACK II; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	KN-2525RB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
D4: lot #: 2208029 or 2209046.E3: occupation: mu logistics & im primary and secondary packaging.H6: investigation findings - code 3221 is based upon the evaluation of user facility information and no sample returned; code 213 is based upon testing of the retention sample.H6 - investigation conclusion - code 4315 is based upon evaluation of user facility information and no device return; code 67 is based upon evaluation of the retention sample.The batch records for lot 2208029 and 2209046 (b)(6) have been reviewed.During needle assembly, as an in-process control, 40 assembled needles (needle assembled with case) are visually inspected twice per shift (8h shift during the week and a 12h shift during the weekend) for foreign matter and damages to the case.No deviations or abnormalities related to your complaint were noted during production.During packaging, as an in-process control, 40 labelled products are visually inspected twice per shift (8h shift during the week and a 12h shift during the weekend) for foreign matter and damages to the case and cap.No deviations or abnormalities related to your complaint were noted during production.During the final inspection (part of the release testing) of (b)(4) pieces, no defects were detected.No relevant deviations or abnormalities were noted in the batch record and during the above-mentioned inspections which relate to your complaint.The lal and sterilization cycle for both lots were executed according to specifications and no observations have been found for these tests.The bioburden monitoring program of 2022 was checked: monitoring results in line with previous years monitoring sampling of (b)(6) 2022 (dates closest to manufacturing date) did not show deviating results.Additionally, no materials of animal origin have been used.Sample investigation: not returned.Retention samples: all remaining retention samples of lot 2208029 have been visually inspected by the naked eye on (b)(6) 2025 for foreign matter and damages which could impact the sterility.No defects have been found.Production investigation: non-conformities.The non-conformities related to the finished product batch and the half-finished product batches of needle assembly have been checked.No related non-conformities were found.Capa: there is no capa related to issues with the sterile barrier system of our products.Based on our investigation including a batch record review and retention sample investigation, no root cause related to our production process has been found.For information regarding the importer report for this event, please refer to section h10.
Event or Problem Description
The user facility reported that the death of a child occurred.The procedure outcome was unknown.

• Brand Name: K-PACK II
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO EUROPE N.V; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer (Section G): TERUMO EUROPE N.V.; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22873432
• Report Number: 9681413-2025-00006
• Device Sequence Number: 16024974
• Product Code: FMI
• UDI-Device Identifier: 05413206003815
• UDI-Public: 05413206003815
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K984576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KN-2525RB
• Device Catalogue Number: KN-2525RB
• Device Lot Number: 2209046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE TO INJECT VACCINE.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 11 MO
• Patient Sex: Unknown